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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No guideline specified, no mention of GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other:
Deviations:
not applicable
Principles of method if other than guideline:
Study rated K4. Information on guideline not available.
GLP compliance:
not specified
Type of study:
open epicutaneous test

Test material

Constituent 1
Reference substance name:
3-methyl-5-propyl-2-cyclohexenone
IUPAC Name:
3-methyl-5-propyl-2-cyclohexenone
Constituent 2
Reference substance name:
celery ketone
IUPAC Name:
celery ketone
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-5-propyl-2-cyclohexenone
- Substance type: No data
- Physical state: liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3-Methyl-5-propyl-2-cyclohexenone (unspecified percentage)
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.03, 0.1, 0.3, 1, 3, 10 and 30% solutions (acetone, ethanol and diethylphthalate solvents) as well as undiluted test material
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.03, 0.1, 0.3, 1, 3, 10 and 30% solutions (acetone, ethanol and diethylphthalate solvents) as well as undiluted test material
No. of animals per dose:
6-8
Details on study design:
RANGE FINDING TESTS: No data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period: 24 hours or 21 days
- Test groups: 6-8 animals per group
- Control group: No data
- Site: flank skin
- Frequency of applications: Single application or once daily (repeated application
- Duration: 24 hours or 21 days
- Concentrations: 0.03, 0.1, 0.3, 1, 3, 10, 30 and 100%

B. CHALLENGE EXPOSURE
- No. of exposures: No data
- Day(s) of challenge: 21 and 35
- Exposure period: 24, 48 and 72 hours
- Test groups: 6-8 animals per group
- Control group: 6-8 animals
- Site: contralateral flank
- Concentrations: 0.03, 0.1, 0.3, 1, 3, 10, 30 and 100%
- Evaluation (hr after challenge): 24, 48 and 72

OTHER: solvents used were acetone, ethanol and diethylphthalate for both induction and challenge exposures, applied volume was 0.1 mL for the induction test and 0.025 mL for the challenge test, application areas were 8 and 2 cm squared for induction and challenge experiments respectively
Challenge controls:
6-8 untreated controls
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 8.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 7.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 7.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
30%
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 7.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 6.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 6.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test material, 3-methyl-5-propyl-2-cyclohexenone, was not found to sensitise the guinea pig in the open epicutaneous test.
Executive summary:

In an open epicutaneous test (OET) using guinea pigs (no guideline specified), the test material 3-methyl-5-propyl-2-cyclohexenone was assessed for sensitisation potential upon single and repeated (21 day) applications, with challenge testing on days 21 and 35 after initial exposure. The test item was not found to sensitise the guinea pig in the OET.